Senior Clinical Research Associate RN - Department of Infectious Diseases

Key Responsibilities

• Lead and manage study start-up activities for multiple clinical trials, including regulatory coordination, site activation, and operational planning
• Oversee and support enrollment-based studies across multiple principal investigators, including studies conducted at partner institutions
• Coordinate day-to-day study operations to ensure timelines, milestones, and compliance requirements are met
• Serve as a central point of contact for study teams, sponsors, and collaborators
• Provide hands-on clinical research support as needed, including serving as a research nurse and assisting with study visits
• Ensure appropriate staffing and coverage for study visits, including those requiring multiple research nurses
• Mentor and provide oversight to research nursing staff, supporting their development in both clinical and project management competencies
• Collaborate with data management, quality assurance, and regulatory teams to ensure high-quality study execution
• Support both pre-activation and post-activation phases of clinical trials, including studies recruiting from community-based settings

Job Responsibilities

• Support project management (lead/monitor planning and delivery) for institutional as well as St. Jude sponsored, multi-center trials, including regulatory, financial, and administrative aspects of the study.
• Act as site study coordinator for complex, large multi-site and/or multidisciplinary clinical trials.
• Maintain and share essential study documents (e.g., investigator files, case report forms) as required.
• Aid in the development of ongoing review of departmental/divisional standard operating procedures and ensure compliance in execution of assigned tasks.
• Support data abstraction, collection, and entry to support clinical research of study team members.
• (As applicable) Perform patient care, education, and management (e.g., routine test conduct; assistance in clinical procedures; medication instruction, monitoring, and documentation; patient care coordination; education on protocol activities).
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Maintain regular and predictable attendance.

Minimum Education and/or Training

Bachelor's degree in Nursing required. Master's degree preferred.

Minimum Experience

Minimum Requirement: 4+ years of experience in carrying out research preferably in healthcare settings. Experience Exception: Master's degree and 2+ years of experience. Experience managing cross-functional communication, including liaison between site and study teams. Experience with documentation and tracking systems/processes. Proven performance in earlier role.

Preferred Skills/Experience

• Several years of clinical research experience, with demonstrated involvement in study start-up and trial management.
• Strong project management and organizational skills, with the ability to manage multiple studies simultaneously.
• Experience working with investigator-initiated trials and multi-site studies preferred.
• Phlebotomy skills strongly preferred.
• Excellent communication, leadership, and problem-solving abilities.